PAT and Lean Manufacturing in Pharma


With regards to process and qc, the pharmaceutical industry has in the past taken a reactive approach. When something broke, it was fixed-that’s, whenever a product-quality issue came about, only then could it have been addressed. Now, however, that’s altering, and also the market is leaving publish-product quality testing and toward an excellent-by-design approach. Which approach meshes well using the twin objectives of lean manufacturing-waste reduction and continuous improvement.

In 2003 the Food and drug administration promulgated its Process Analytical Technology (PAT) initiative to “let the voluntary development and implementation of innovative pharmaceutical manufacturing and quality assurance.” This initiative is built to improve process efficiencies, both manufacturing and regulatory, and it has four components: data analysis, process analytical tools, process monitoring, and continuous feedback. The standard-by-design facet of PAT will reduce cycle time thus lowering the wastes of waiting and inventory recognized by lean manufacturing.

In early stages, efforts with PAT were focused chiefly around the single facet of developing and applying analytical tools for timely in-process measurements. But to completely realize PAT’s objective of complete understanding and charge of the manufacturing process, a larger toolkit can be used. The various tools suggested through the Food and drug administration are multivariate tools (to deal with design, information gathering, and analysis), tools for process analysis, tools for process control, and tools for continuous improvement. Then, using these tools, pharmaceutical manufacturers can move toward goals shared by PAT and lean manufacturing: reduced cycle occasions, less rejects, elevated automation, and continuous improvement along the way.

Still, the pharmaceutical industry continues to be slow to consider towards the PAT initiative and also to lean manufacturing solutions as well as for largely exactly the same reasons. The primary reason, and most likely the toughest to beat, is a getting related to cultural issues and mindset. Within this industry a decades-lengthy attitude of risk aversion has created a narrow concentrate on staying away from mistakes instead of improving processes. So error-free documentation (which largely paper-based) gets to be more important than radical understanding from the process. The issue here’s that PAT requires a danger-based approach and process understanding.

Additionally, some companies and a few divisions within plants just aren’t technologically ready for advanced control. Some still use chart recorders where operators by hand record data in writing batch records. Beginning out of this early transformative stage regarding technologies have a massive negative effect on a company’s capability to evaluate data and control processes, take necessary corrective and preventive steps, and pursue continuous process improvement.

The pharmaceutical industry continues to be similarly slow in fully adopting lean manufacturing due to the fact of, again, culture and mindsets. The is extremely compartmentalized, so the manufacturing process consists of many discrete parts instead of as being a continuous, integrated flow. It’s tough to enhance a procedure that is not a significant process yet. Also, there is a desire not to make necessary changes when altering a load size means the additional burden of intensive documentation and testing. Just like PAT, the stuff that need improvement prevent companies from taking the steps needed toward that improvement.

It appears the concepts from the FDA’s PAT initiative and lean manufacturing solutions are very well suitable for operate in symphony or at best together. They’ve similar goals and other alike obstacles for their full implementation-obstacles that may appear much less daunting when pharmaceutical consultants and lean manufacturing consultants part of.

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